Healios entered into a joint development agreement with Sumitomo Dainippon Pharma Co., Ltd. in 2013. Under the agreement, Sumitomo Dainippon Pharma provides funds to Healios for co-developing iPS cell–derived human retinal pigment epithelial (RPE) cells and obtaining approval for the manufacture and sales of such products. Additionally, our two companies established a joint venture, Sighregen, in 2014 to promote the manufacture and sales of commercialized RPE cell products.
Healios is also working with SHIBUYA KOGYO CO., LTD., Nikon Corporation and Osaka University on the development of an automated culturing device with a view towards greater manufacturing efficiency. In such ways, we are building a strong development ecosystem and value chain so that we can promote the practical application of iPSC regenerative medicine products.
We are also planning for Healios-led development outside Japan. To date, we have completed the selection of manufacturing subcontractors in the US and European markets. We have also embarked on technology transfers to those subcontractors, and are in consultations with US regulatory authorities.
The name “Sighregen” is derived from the words “Sight” and “Regeneration.”
By capitalizing on the synergy between the manufacturing and marketing know-how of a pharmaceutical firm, Sumitomo Dainippon Pharma, and our own experience in the cell-culture field, Sighregen plans to manufacture safe and effective iPSC regenerative medicine products and drive strong sales growth.
The chart below illustrates the flow of business and funding between Healios, Sumitomo Dainippon Pharma, and Sighregen.
We receive an offer from CiRA (Kyoto University) for a parent iPS cell strain and entrust production (cultivation (differentiation) & pharmaceutical manufacture) to Sighregen. After we have obtained manufacturing and sales rights, we sell the products to medical institutions. All sales promotion activities focused on medical institutions are outsourced to Sighregen.
We at Healios are not just a research and development firm; as a pharmaceutical corporation, our goal is to establish a business organization encompassing us, Sighregen, and other business partners to handle everything from R&D to obtaining manufacturing and sales rights to actual production and sales.
Healios entered a collaborative research and exclusive option agreement with Universal Cells, Inc. in 2016. Universal Cells is a private biotechnology company developing proprietary nuclease-free genome editing technologies that allow efficient and accurate editing of any gene without cutting the genome. The company is using this platform to create cell therapies that are rejection-free, off-the-shelf products that can be administered to any recipient without the need for immunosuppressive drugs. Healios has started to investigate whether Universal Donor Stem Cells technology developed by Universal Cells can be applied to iPSC regenerative medicine.
Healios entered into license agreement with Athersys, Inc. for the development of regenerative medicine products that will be developed and marketed in Japan by Healios, making use of Athersys’ proprietary, patented stem cell product, MultiStem® cell therapy. We have started clinical study for ischemic stroke using MultiStem.